Assessing feasibility and effectiveness of point-of-care limited HPV genotype tests in cervical cancer screening: a modelling study

BackgroundCervical cancer (CaCx) remains a significant cause of morbidity and mortality, especially among women in sub-Saharan Africa, where only 15% of women have undergone screening. To address these substantial screening gaps, the WHO recommends human papillomavirus (HPV) DNA detection as the primary screening method. One strategy to improve screening coverage is the use of limited HPV genotype target tests which can be offered as true point-of-care (POC) tests. However, understanding the conditions under which limited-genotype tests can compete with existing full genotype testing remains a barrier to their development and adoption. We explored the trade-offs between accessibility, retention, costs, and test performance to inform the development of new POC limited-genotype tests. MethodsWe developed a once-off HPV screening model to investigate the potential use-cases and required specifications of limited-target POC tests. We estimated the proportion of cases of cervical intraepithelial neoplasia grade 2+ (CIN2+) and the testing costs per case identified for three scenarios: (1) limited-genotype tests alone, (2) full-genotype tests, and (3) limited-genotype rule-in tests followed by full-genotype testing for those screening negative. We compared screening program performance across ranges of screening coverage, genotype target capture, loss to follow-up, and test price to identify the conditions where limited-genotype screening was non-inferior to full-genotype screening. ResultsWhen coverage and retention following full-genotype screening were high, limited-genotype tests were only competitive at a very low cost. However, with either modest increases ([&ge;]5%) in screening coverage or higher loss to follow-up after full-genotype screening ([&ge;]19.8%), an 8-target limited-genotype test could identify the same number of CIN2+ cases as full-genotype screening, but must cost <US$8.50 to be cost-equivalent. Adding full-genotype testing following a rule-in 4-target test would be as effective as full-genotype screening in the number of CIN2+ cases identified; the limited-genotype test must cost <US$2.20 to be cost-equivalent. ConclusionsOur modeling supports screening with an 8-target limited-genotype HPV POC test priced at <US$8.50 for cost-equivalence with full-genotype screening. A rule-in 4-target test will be cost-equivalent if priced at <US$2.20. These insights can enhance CaCx screening access and support the goal of eliminating CaCx in sub-Saharan Africa.